FDA Adverse Event
Injury
Summary report: N
WILSON - COOK MEDICAL INC
MDR report key: 217867
·
Received April 6, 1999
Report
- Report Number
- 217867
- Event Type
- Injury
- Date Received
- April 6, 1999
- Date of Event
- April 5, 1999
- Report Date
- April 5, 1999
- Manufacturer
- WILSON - COOK MEDICAL INC
- Product Code
- KNQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RADIOLOGICALLY ASSISTED PLACEMENT OF GUIDEWIRE TO STOMACH; DILATOR PASSED OUR GUIDEWIRE EASILY; UNABLE TO PULL GUIDEWIRE OUT WITH 2 ATTEMPTS; WHEN BOTH DILATOR & GUIDEWIRE PULLED OUT; GUIDEWIRE BENT NEAR END (2 1/2" FROM END).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WILSON - COOK MEDICAL INC | STANDARD WIRE GUIDE | KNQ | WILSON - COOK MEDICAL INC | * | 102875308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |